PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00948402

First Posted: July 29, 2009

Last Update Posted: October 14, 2009

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Information provided by:

Federico II University

Purpose

Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p<0.001, respectively). After treatment, independently of body weight, only in MET group PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein over-expression in obese PCOS women with IR reduced after a six month treatment with MET, while remained unchanged in the OCP group. The reduction was independent of body weight, and correlated with insulin sensitivity indexes. This effect further supported MET as a more effective therapy than OCPs for obese PCOS women with IR, also when fertility is not required.

Condition	Intervention	Phase
Polycystic Ovarian Syndrome Insulin Sensitivity	Drug: Metformin Drug: oral contraceptive	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Allergy Polycystic Ovary Syndrome

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:

PED/PEA-15 protein expression [ Time Frame: 6 months ]

Secondary Outcome Measures:

BMI, plasma glucose, plasma insulin, insulin sensitivity indexes (1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI, whole-body insulin sensitivity index). [ Time Frame: 6 months ]


Enrollment:	20
Study Start Date:	December 2006
Study Completion Date:	January 2009
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: metformin	Drug: Metformin metformin 1250 mg three times daily Other Name: Biguanides
Active Comparator: oral contraceptive	Drug: oral contraceptive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month. Other Name: estroprogestins

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 28 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

female
premenopausal
obesity
PCOS.

Exclusion Criteria:

pregnancy
type 2 diabetes or impaired glucose tolerance
hypothyroidism
hyperprolactinaemia
Cushing's syndrome
nonclassical congenital adrenal hyperplasia
previous (within the last 6 months) use of oral contraceptives
glucocorticoids
antiandrogens
ovulation induction agents
antidiabetic and antiobesity drugs, or other hormonal drugs.

None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948402

Sponsors and Collaborators

Federico II University

Investigators


Principal Investigator:	Annamaria Colao, MD PhD	Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Savastano S, Di Somma C, Pizza G, De Rosa A, Nedi V, Rossi A, Orio F, Lombardi G, Colao A, Tarantino G. Liver-spleen axis, insulin-like growth factor-(IGF)-I axis and fat mass in overweight/obese females. J Transl Med. 2011 Aug 16;9:136. doi: 10.1186/1479-5876-9-136.

Savastano S, Valentino R, Pizza G, De Rosa A, Orio F, Passaretti F, Formisano P, Lombardi G, Beguinot F, Colao A. Preliminary data on effects of metformin on PED/PEA-15 cellular levels in obese women with polycystic ovary syndrome. J Endocrinol Invest. 2010 Jul-Aug;33(7):446-50.


Responsible Party:	Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples
ClinicalTrials.gov Identifier:	NCT00948402 History of Changes
Other Study ID Numbers:	NeuroendoUnit-11
First Submitted:	July 24, 2009
First Posted:	July 29, 2009
Last Update Posted:	October 14, 2009
Last Verified:	October 2009

Keywords provided by Federico II University:


PED/PEA-15 protein PCOS IR	metformin OCP Oral Contraceptive

Additional relevant MeSH terms:


Syndrome Hypersensitivity Insulin Resistance Polycystic Ovary Syndrome Disease Pathologic Processes Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ovarian Cysts Cysts Neoplasms	Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Metformin Contraceptive Agents Contraceptives, Oral Hypoglycemic Agents Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female

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